Healthy
Conditions
Brief summary
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine, and feces in man following a single dose of \[14C\] YH4808 200 mg (\ 100 µCi ±20 µCi) administered as a single oral dose.
Detailed description
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Study Entry (ie, prior to Check-in \[Day -1\]). Subjects will be confined at the Clinical Research Unit (CRU) from Check in (Day -1) until Discharge Criteria have been met (as early as Day 6 and as late as Day 11). In this study design, physical examinations, electrocardiograms (ECGs), vital signs, How do you feel? (HDYF?) Inquiries, and clinical laboratory evaluations will be performed at Screening, at specified times during the study, and/or at Clinic Discharge. All AEs, whether volunteered, elicited, or noted on physical examination, will be recorded throughout the study (ie, from dosing on Day 1 until Clinic Discharge \[Day 11\]).
Interventions
DRUG[14C]-YH4808 200 mg
\[14C\]-YH4808 200 mg (oral) on day1
Sponsors
Yuhan Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* clinical laboratory evaluations within the reference range for the test laboratory * negative test for selected drugs of abuse, hepatitis panel and HIV antibody screens * able to comprehend and willing to sign an Informed Consent Form
Exclusion criteria
* significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs * participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in * donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8) | Day1-Day11 | * Maximum observed concentration in plasma, whole blood, urine, and feces * Time to maximum observed concentration in plasma, whole blood, urine, and feces * Area under the concentration-time curve from Hour 0 to the last measurable concentration * Assessment of Mass balance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterization and identification of metabolites of [14C]-YH4808 in plasma, urine, and feces | Day1-Day11 | — |
| assessment of the safety and tolerability of YH4808 | Day1-Day11 | * Clinical laboratory tests * 12-lead ECGs * Physical examinations * Vital signs * Adverse event assessments |
Countries
United States
Outcome results
None listed